This analysis examines the extent to which order of market entry influences the prospects of achieving a satisfactory return on investment for companies developing branded generic and generic inhaled products. The analysis shows that, in some cases, sufficiently attractive financial gains cannot be expected beyond the first few market entrants, as indicated by the appearance of negative net present values for later entrants. This emphasizes the importance of developers paying close attention to, and making frank assessments of, their ability to reach the market ahead of their competitors.

This report addresses the following questions:

What are the regulatory requirements for approval of generic inhaled products in Europe and the US?

What market share can manufacturers of generic inhaled products expect to achieve depending on their order of market entry?

Which branded inhaled products should generic manufacturers target in order to achieve commercial success

What factors should generic inhaled product manufacturers assess when deciding on the economic viability of a new product?

An absence of head-to-head trials, along with biosimilar launches, provide payers with leverage to demand favorable pricing for branded products in exchange for formulary access.

This report addresses the following questions:

What access controls are payers imposing on interleukins in psoriatic arthritis?

What discounts and market access levers will be required to drive uptake of interleukins and second-generation TNFalpha inhibitors?

How do US and European payers view the launch of oral small molecules in psoriatic arthritis?

What impact will biosimilar entry have on pricing and reimbursement of branded biologics?